Sleep ApneaNCT04764734
A Validation Study of the NightOwl Home Sleep Apnea Test
A study testing NightOwl in people with Sleep Apnea, run by Ectosense NV at 4 sites in United States.
Trial summary
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- NightOwl
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Mar 2021to 10 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects with an indication for an in-lab polysomnography
Who cannot join
- Intellectually disabled people
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Coral Springs Laboratory
Coral Springs, Florida, 33071
United Sleep Diagnostics Hollywood Laboratory
Hollywood, Florida, 33021
Miami Lakes Laboratory
Miami Lakes, Florida, 33016
United Sleep Diagnostics Pembroke Pines Laboratory
Pembroke Pines, Florida, 33024
About this study
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the apnea hypopnea index (AHI) estimate, defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. This study will be performed in a sleep lab environment.
- Conditions
- Sleep Apnea
- Being tested
- NightOwl
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NightOwlDevice
The NightOwl is a finger-mounted home sleep apnea testing device
| Study group | Role | What they receive |
|---|---|---|
| PSG and NightOwl | Experimental | During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with the informed consent form. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam. Receives: Device: NightOwl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization
The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants.
Measured: Through study completion, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start20 Mar 2021
- Primary completion5 Sep 2022 (estimated)
- Study completion10 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ectosense NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jagdeep Bijwadia, MD MBA, Principal investigator, SleepMed RX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764734
- Sponsor's protocol ID
- NightOwl-02
- Status last verified
- Sep 2022
- First submitted
- 18 Feb 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of the NightOwl Home Sleep Apnea Test
- ClinicalTrials.gov ID
- NCT04764734
- Acronym / sponsor ID
- NightOwl-02
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ectosense NVIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 5 Sep 2022 (estimated)
- Study completion
- 10 Sep 2022 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the apnea hypopnea index (AHI) estimate, defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. This study will be performed in a sleep lab environment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test
| Arm | Type | Receives |
|---|---|---|
| PSG and NightOwl | Experimental | Device: NightOwlDuring the study, for each execution day, all patients that have been scheduled for a PSG will be presented with the informed consent form. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with an indication for an in-lab polysomnography
Key exclusion criteria (1 listed)
- Intellectually disabled people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NightOwlThe NightOwl is a finger-mounted home sleep apnea testing device | Device | PSG and NightOwl |
Primary outcome
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization
Time frame: Through study completion, an average of 1 month.
The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jagdeep Bijwadia, MD MBA principal investigator
SleepMed RX
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NightOwl in people with Sleep Apnea, run by Ectosense NV at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization (time frame: Through study completion, an average of 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.